Associate Manager/ Manager, Quality Assurance
Core
Establishing, implementing, and maintaining a Quality Management System for pharmaceutical products in compliance with GxP (GDP, GMP) and regulatory standards.
Role type
Manager, Quality Assurance (Pharmaceuticals)
Builds
Regulatory compliant product distribution and quality assurance processes
Domain
Pharmaceuticals / Good Distribution Practice (GDP)
Deliverable
client delivery
Required skills
GxP regulatory compliance, Quality Management System (QMS) management, supplier/customer auditing, CAPA system management, change control, internal auditing, product release decision-making, complaint and recall management, controlled drugs management
Preferred skills
Trained internal auditor for GMP/GDP, proficiency in Microsoft Office
Technologies
Microsoft Office Applications
Responsibilities
Ensure appropriate certification (GMP, GDP, ISO, etc.) is attained and sustained; Liaise with regulatory authorities for licensing and product list compliance; Investigate and report deviations, complaints, recalls, and suspected falsified products; Manage internal audit programs and track actions as CAPA; Approve subcontracted activities and changes impacting GxP; Ensure compliance of repacking, storage, and distribution with GDP regulations; Manage controlled drugs per authority requirements.
Seniority
Manager, operational management
